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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ULTRADENT PRODUCTS, INC. VALO CORDLESS BATTERY CHARGING UNIT

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ULTRADENT PRODUCTS, INC. VALO CORDLESS BATTERY CHARGING UNIT Back to Search Results
Model Number 5962
Device Problem Environmental Compatibility Problem
Event Date 07/28/2017
Event Type  Malfunction  
Event Description

An email was received on (b)(6) 2017 from a dentist in (b)(6) in regards to a fire that occured a month prior (exact date unknown at this time) at a naval dental clinic in (b)(6). The dentist was asking what we could tell him about a fire that may have occured due to a valo battery charger over heating. After a review of the complaint data base and employee interviews we determined we had no prior knowledge of this event and a call was placed to the facility were we were told it occured. The person at the clinic informed our government accounts manager that he did not have all the information and would call our complaints department. Our customer satisfaction manager did make contact with the two people involved with the fire investigation, the following is known at this time:+ · the fire started at 2:00 am on (b)(6) in the (b)(6) clinic. These are old navy buildings with old wiring. · the source of the fire was definitely from the area of the battery charger in an additional room in the clinic. · an assistant plugged two battery charging units into the same wall outlet and sat the chargers on a metal table. · it was burned inside the wall by the battery charger. · the clinic has over 100 chargers with batteries. They charge 1-3 hours every 2 wks. As of september 09, 2017 nobody from the clinic involved has made contact. Phone call to facility on september 12th 2017- they were not authorized to give us any information. If further information is obtained mdr will be updated if needed. Filing an mdr out of an abundance of caution in the event valo was involved.

 
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Brand NameVALO CORDLESS BATTERY CHARGING UNIT
Type of DeviceVALO CORDLESS BATTERY CHARGING UNIT
Manufacturer (Section G)
ULTRADENT PRODUCTS, INC.
505 w ultradent drive
south jordan UT 84095
Manufacturer Contact
505 w ultradent drive
south jordan , UT 84095
8015534500
MDR Report Key7139680
Report Number1718912-2017-00044
Device Sequence Number1
Product CodeEBZ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Remedial Action Replace
Type of Report Initial
Report Date 12/21/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/21/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number5962
Device Catalogue Number5962
Device LOT NumberUNABLE TO OBTAIN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/28/2017
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 12/21/2017 Patient Sequence Number: 1
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